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WO2016107057A1 - 一种全自动荧光免疫定量分析装置及检测方法 - Google Patents

一种全自动荧光免疫定量分析装置及检测方法 Download PDF

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Publication number
WO2016107057A1
WO2016107057A1 PCT/CN2015/079758 CN2015079758W WO2016107057A1 WO 2016107057 A1 WO2016107057 A1 WO 2016107057A1 CN 2015079758 W CN2015079758 W CN 2015079758W WO 2016107057 A1 WO2016107057 A1 WO 2016107057A1
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WO
WIPO (PCT)
Prior art keywords
module
sample
reagent strip
loading
reaction
Prior art date
Application number
PCT/CN2015/079758
Other languages
English (en)
French (fr)
Inventor
苏恩本
陈维森
尹凌志
王林
李靖
金晶
Original Assignee
基蛋生物科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 基蛋生物科技股份有限公司 filed Critical 基蛋生物科技股份有限公司
Priority to US15/309,083 priority Critical patent/US10338064B2/en
Priority to SG11201609288YA priority patent/SG11201609288YA/en
Publication of WO2016107057A1 publication Critical patent/WO2016107057A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/025—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having a carousel or turntable for reaction cells or cuvettes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
    • G01N35/1011—Control of the position or alignment of the transfer device
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099—Characterised by type of test elements
    • G01N2035/00108—Test strips, e.g. paper
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00178—Special arrangements of analysers
    • G01N2035/00326—Analysers with modular structure
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels
    • G01N2035/0444—Rotary sample carriers, i.e. carousels for cuvettes or reaction vessels
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/046—General conveyor features
    • G01N2035/0465—Loading or unloading the conveyor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0474—Details of actuating means for conveyors or pipettes
    • G01N2035/0482—Transmission
    • G01N2035/0484—Belt or chain
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0496—Other details
    • G01N2035/0498—Drawers used as storage or dispensing means for vessels or cuvettes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N2035/1027—General features of the devices
    • G01N2035/103—General features of the devices using disposable tips

Definitions

  • the invention belongs to the field of quantitative fluorescence immunoassay detection, and particularly relates to a fully automatic fluorescence immunoassay method and device.
  • IVD in vitro diagnostic equipment
  • the existing fluorescent immunochromatography analyzer GP1100 of Nanjing Basic Egg Biotechnology Co., Ltd. is a semi-automatic testing instrument, and its machine structure is only Including an optical path system and electronic display system for quantitative inspection, the loading and chromatography processes are done manually outside the machine; in use, first of all, because semi-automatic instruments are used for outdoor loading, for some temperatures are very high. The product inspection is very unfavorable; secondly, because manual sampling and sample loading steps are required, and then quantitative analysis by the instrument, the test error caused by manual intervention is increased, the immunochromatography layering time, the sampling accuracy, etc.
  • the present invention discloses a fully automatic fluorescent immunological quantitative analysis device and a detection method thereof, which can repeatedly perform the fluorescence immunological quantitative detection work continuously, and has high sensitivity, simple operation and high repeatability.
  • a fully automatic fluorescent immunological quantitative analysis device comprising a support bottom plate, a reagent strip storage and automatic loading module, a reaction disk module, a detection module, a sample module, a sample loading module, a washing module and a control system
  • the reagent strip storage and automatic loading module, the reaction disk module, the detecting module, the sample module, the loading module, and the washing module are sequentially arranged on the supporting bottom plate, and the reagent strip is stored
  • the storage and automatic loading module provides a reagent strip for the reaction disk module, and the sample loading module adds the sample in the sample module to the reaction disk module for reaction, and after completing the reaction, enters the detection module to complete the detection.
  • the loading module comprises an XYZ moving robot arm, a disposable tip picker and a syringe pump;
  • the XYZ moving robot arm comprises an X arm, a Y arm and a Z arm, and the X arm is horizontally arranged along the sample module and the reaction disk module;
  • the Y arm Located in the upper part of the sample module, it is vertically connected to the X arm and can slide on the X arm.
  • the Z arm is vertically fixed in the sliding groove of the Y arm. It can be moved back and forth along the Y arm, and the disposable tip picker is installed at the bottom of the Z arm. .
  • the stepper motor assembly is connected to the XYZ arm, and the control system controls the stepping motor assembly to control the sliding of the Y and Z arms, so that the disposable tip picker can move up and down and left and right in the sample module and the reaction disk module area.
  • the sample module comprises a disposable tip box, a mixing box, a diluent tank, a sample unit, a tip collection box and a sample module box, wherein the sample unit and the diluent tank are located on the bottom plate of the sample module box, and the bottom plate is provided with
  • the track, the sample unit and the bottom of the dilution tank are arranged with the card slot matched with the track, the sample unit and the diluent tank slide back and forth on the floor track;
  • the platform of the sample module box is arranged on the side, the lower part of the platform is separated, the suction head is recycled, and the disposable
  • the tip box and the mixing box are discharged on the platform, and the part of the suction box of the suction head passes through the platform, and on the platform, part of the space is in the lower part of the platform, the top of the suction box is provided with a recovery port, and the bottom end is not sealed, sucking The head enters the recovery port and falls directly onto the bottom plate.
  • the sample module box is arranged in a drawer shape, and has baffles on the left and right sides.
  • the outer side of the baffle has a pulley, which can slide back and forth along the outer slide rails, and a front end of the baffle has a fixed latch for fixing the drawer.
  • the reaction disk module is a disc-shaped device, the disc edge fixed the reagent strip slot, the slot mouth and the reagent strip storage and the auto-loading module correspond to the reagent strip exit position, loading the reagent strip; the reaction disc will take the reagent strip
  • the sample loading operation is completed at the position corresponding to the loading module; the reaction tray takes the reagent strip to the position corresponding to the detecting module to complete the detecting operation.
  • the reaction disk is connected to the first motor, and the first motor drives the first synchronous wheel and the first synchronous belt to drive the reaction disk to rotate;
  • the reaction plate reagent strip slot is 2N or 2N+1, N ⁇ 1, reagent strip
  • the slots are preferably 16-20, and more preferably the reagent strip slots are 16.
  • the reagent strip storage and automatic loading module comprises a reagent strip storage box, a storage box bracket and an automatic loading component, the storage box bracket is fixed on the support bottom plate, and the reagent strip storage box is fixed on the storage box bracket by a buckle; the automatic loading component is The second motor, the second synchronous wheel, the second synchronous belt and the elastic hanging rod are formed, and the control system controls the second motor to drive, and drives the second synchronous wheel, the second synchronous belt, and the elastic hanging rod to move.
  • Said A reagent strip slot is disposed in the reaction plate module, and a gap is formed in the middle of the lower bottom surface, and the notch allows the elastic hanging rod to send the reagent strip into the reagent strip slot.
  • the elastic hanging rod is a rod, which is located under the reaction strip reagent strip slot, and can reciprocate under the reaction tray and the storage box along the straight line of the slot, and the front end rod portion has a resilient hook with a pressing force. When working, it enters under the reagent strip, and the hook is pressed down by the reagent strip until it enters the groove below the reagent strip to recover. The movement moves back from the storage box to the reagent strip slot of the reaction tray, and the hook is re-entered when exiting. Press down to exit the reagent strip groove.
  • the reagent strip storage box comprises a box body and a lid portion, the box body and the lid are sealed; the reagent strip storage box has a reagent strip descending rail; the reagent strip storage box has a notch at the bottom thereof, and the reagent strip storage box side is adjacent to the strip
  • the bottom end of the notch has a sealing elastic piece; the notch extends from the bottom end side of the reagent strip storage box to the other side, and the extending length thereof may be from a notch corresponding to the reagent strip to the other side of the bottom end,
  • the sealing shrapnel can only be bounced outside the reagent strip storage box.
  • a desiccant receptacle for placing a desiccant is placed on the wall of the reagent strip storage case.
  • the reagent strip descending rail may be a rail attached to the inner wall of the reagent strip storage box, or a rail suspended from the top, and the distance between the reagent strip descending rail and the bottom end of the reagent strip storage box is 1-2 reagent strips. Between thicknesses.
  • a sensor can be placed on the reagent strip storage box holder assembly, and the number of remaining reagent strips can be counted by the sensor.
  • the detecting module is disposed on the supporting bottom plate and located at the periphery of the reaction turntable so that the reagent strip in the reaction tray can be detected under the rotation.
  • the detection module includes an optical detection device, and the reagent strip in the reaction tray is rotated to the detection device to complete the fluorescence detection.
  • the bottom of the detecting module is provided with an elastic hanging rod. After the detecting module completes the detection of the reagent strip, the elastic hanging rod under the detecting module pushes the reagent strip out of the reaction tray and enters below the detecting device. After the next reagent strip has been tested, the previous reagent strip is pushed out of the device of the present embodiment by the next reagent strip, and the next reagent strip remains below the detection device.
  • the elastic hanger at the bottom of the module is the same as the flexible hanger mechanism below the reagent strip slot of the reaction tray.
  • the washing module comprises a washing needle tank, a waste liquid bottle and a washing liquid bottle, and a pipe in the washing needle tank is connected with the waste liquid bottle and the washing liquid bottle.
  • Another object of the present invention is to provide a method for detecting a fully automated fluorescent immunoassay comprising the following steps:
  • Step 1 The reagent strip storage and automatic loading module loads the reagent strip into the reagent strip slot in the reaction tray;
  • Step 2 The reaction tray starts to rotate, and the reagent strip in the first position enters the sample loading area and stops, and the sample loading module samples the sample in the module and adds the reagent strip addition port to start the immunochromatographic reaction;
  • Step 3 The reaction tray continues to rotate, the reagent strip in the first position leaves the sample application area, and the reagent strips in the subsequent position enter the sample application area successively, and are successively paused to complete the sample loading;
  • Step 4 The reaction tray continues to rotate, the first position reagent strip is rotated to the detection module, and the detection device completes the detection of the reagent strip at the first position, and sends the result to the computer for processing.
  • the loading step includes the following two cases:
  • sample loading device first picks up the disposable tip, then moves to the sample area to take the sample, then moves to the reaction plate area to complete the sample loading process, and then the sample loading device moves to the disposable tip collection box recovery port. Remove the disposable tip and perform a new round of loading;
  • the sample loading device first picks up the disposable tip, and the sample area of the movement absorbs the sample, then moves to the dilution tank to add the sample to the dilution tank, and then sucks the diluent into the sample, and repeatedly draws and samples the sample. After dilution, move to the reaction plate loading area to complete the sample loading, then carry out the disposable tip recovery, and then pick up the new tip for a new round of loading after moving to the disposable tip box.
  • a plurality of samples can be discharged in the sample module.
  • the invention solves the problem that the in vitro diagnostic product is difficult to realize automation by providing a fully automatic fluorescent immunological quantitative analysis device, avoids cross-contamination by the disposable aspirating device, and has precise reaction time control, and improves the repeatability and accurate test of the instrument. Degree, the automatic test of the rapid diagnostic instrument is realized, the human error is reduced, the precision of the test is improved, and the detection efficiency is improved.
  • the invention can realize detection of a plurality of samples together.
  • the invention is applicable to both direct sample detection and dilution sample detection.
  • the invention adds a drying hole in the reagent strip storage box, can ensure the drying of the reagent strip and improve the detection accuracy.
  • the invention comprises a liquid path washing system capable of ensuring that the disposable tip picker is cleaned so that the sucked sample is not contaminated.
  • Fig. 1 Schematic diagram of the control system structure of the automatic fluorescent immunoassay device.
  • Figure 2 is a perspective view of a fully automated fluorescent immunoassay device.
  • Figure 3 is a top view of the fully automated fluorescent immunoassay device.
  • Figure 4 is a schematic diagram of the structure of the stent of the automatic fluorescent immunoassay analyzer.
  • Figure 5 shows the structure of the sample module.
  • Figure 6 is a schematic diagram of the structure of the reaction disk module.
  • Figure 7 shows the storage structure of the reaction plate without reagent strips.
  • Figure 8 is a schematic diagram of the structure of the reagent strip storage, that is, the automatic loading module.
  • Figure 9 is a schematic view showing the structure of the reagent strip storage case and the holder assembly.
  • Figure 10 is a schematic view showing the external structure of the reagent strip storage case.
  • Figure 11 is a schematic view showing the internal structure of the reagent strip storage case.
  • Figure 12 is a schematic view showing the structure of the automatic ejection device of the reagent strip storage box.
  • Figure 13 is a schematic flow chart of the method of automatic fluorescent immunoassay.
  • 1 is the support bottom plate
  • 2 is the circuit box
  • 3 is the reagent strip storage and automatic loading module
  • 4 is the reaction disk module
  • 5 is the detection module
  • 6 is the sample module
  • 7 is the sample loading module
  • 8 is the washing module
  • 9 is the X arm
  • 10 is the Y arm
  • 11 is the Z arm
  • 12 is the disposable tip picker
  • 13 is the stepper motor assembly
  • 14 is the pulley
  • 15 is the slide rail
  • 16 is the fixed plug
  • 17 is the disposable suction
  • the head box, 18 is a mixing box
  • 19 is a diluent tank
  • 20 is a sample unit
  • 21 is a head collection box
  • 22 is a track
  • 23 is a platform
  • 24 is a recovery port
  • 25 is a rack
  • 26 is a reagent strip slot.
  • 27 is the reagent strip outlet
  • 28 is the reagent strip slot notch
  • 29 is the first motor
  • 30 is the first synchronous wheel
  • 31 is the first synchronous belt
  • 32 is the reagent strip storage box
  • 33 is the storage box bracket
  • 34 is Buckle lock
  • 35 is the second motor
  • 36 is the second synchronous wheel
  • 37 is the second timing belt
  • 38 is the elastic hanging rod
  • 39 optical detecting device 40 is the front box plate, 41 is the needle washing tank, 42 is the syringe pump 43 is a liquid washing bottle
  • 44 is a waste liquid bottle
  • 45 is an automatic loading component
  • 46 is a reagent strip descending rail
  • 47 is a notch
  • 48 is a sealing elastic piece
  • 49 is a desiccant jack.
  • Sensor 50 the reagent strip 51 tracks.
  • a fully automatic fluorescent immunoassay device includes a support base plate 1 and a control system, and further includes a reagent strip storage and automatic loading module 3 and a reaction disk module 4 arranged in sequence on the bottom plate.
  • the reaction is carried out on the reagent strip of 4, and after completion of the reaction, it enters the detection module 5 to complete the detection.
  • the loading module 7 includes an XYZ moving robot arm and a disposable tip picker 12; the X arm 9 is horizontally disposed at the top of the circuit box 2, and the Y arm 10 is located in the sample module 6.
  • the upper portion is vertically connected to the X arm 9, and the Y arm 10 is slidable on the X arm 9.
  • the Z arm 11 is vertically fixed in the sliding groove of the Y arm 10, and can be slid back and forth along the Y arm 10.
  • a disposable tip pickup 12 is attached to the bottom of the Z-arm 11.
  • the stepping motor assembly 13 is connected to the XYZ arm, and the stepping motor assembly 13 is controlled by the system to control the sliding of the Y and Z arms, so that the disposable tip picker 12 can be up and down in the sample module 6 and the reaction panel module 4 area. mobile.
  • the circuit box 2 includes various control devices such as a line and a main control board.
  • the sample module 6 is a drawer-like device, and has baffles on the left and right sides.
  • the outer side of the baffle has a pulley 14, which can slide back and forth along the outer slide rail 15, and a fixed latch 16 is arranged at the front end of the baffle.
  • the drawer can be fixed;
  • the module includes a disposable tip box unit 17, a mixing box 18, a diluent tank 19, a sample unit 20 and a tip collection box 21;
  • the sample unit 20 is located on the bottom plate of the drawer and passes through the bottom plate.
  • the track 22 is fixed and can be slid forward and backward; the drawer is provided with a platform 23, and the lower portion thereof is separated, and the suction head recovery box 21, the disposable tip box 17 and the mixing box 18 are sequentially discharged on the platform 23, and the suction is performed.
  • a portion of the head recovery box 21 passes through the platform 23 on the platform 23, and a portion is under the platform 23.
  • the top end of the suction head recovery box 21 is provided with a recovery port 24, and the bottom end is empty.
  • the suction head enters the recovery port 24 and directly falls onto the bottom plate.
  • the disposable tip box 17 and the mixing box 18 are supported by the frame of the holder 25.
  • the diluent tank 19 is located between the sample unit 20 and the platform 23, and also has a bottom rail 22 fixed to the bottom plate.
  • the reaction disk module 4 is a disk-shaped device, and 16-20 reagent strip slots 26 are fixed at the edge of the disk, wherein the slot port and the reagent strip storage and automatic loading module 3
  • the reagent strip outlet 27 corresponds to the position, and the reagent strip storage and autoloading module 3 can push the reagent strip into the reagent strip slot 26;
  • the lower portion of the reaction disc module 4 is connected to the first motor 29 via the bottom plate and the bottom plate bottom, and the first motor 29 is connected
  • the control system is connected, and the control system drives the first synchronous wheel 30 and the first synchronous belt 31 by regulating the first motor 29. Finally, the rotation of the reaction disk is controlled.
  • the detecting module 5 is located between the reagent strip storage and automatic loading device 3 and the circuit box 2, and has an immunofluorescence detecting device 39 thereon, and the reagent strip in the reaction tray is rotated to the detecting device to complete Fluorescence detection.
  • the circuit box 2 is fixed to the bottom plate 1, and includes a box top, a front box 40, a rear box and a side box; wherein the front box has a washing slot 41
  • the tank has a conduit connected to the waste liquid bottle 44 and the liquid washing bottle 43 located outside the side tank plate; the front tank plate also has a syringe pump 42 connected to the disposable tip picker 12.
  • the device of the invention also passes corresponding information through an output module, such as an external computer, a printer, a touch display
  • the automatic fluorescent immunoassay device control system comprises a power interface (P1), a main control board, a touch display screen, an external interface (P10), an RFID module, a scanner module, a printer module, Photocell signal input, motor driver group, motor, auto-loading module, infrared sensor and other sensors; the power supply interface is filtered by the mains via the power supply filter, and then converted to 24V DC power supply by the switching power supply to the main control board. And related modules.
  • the main control board is the instrument control center, which loads the main control program, collects the sensor information of each channel, accepts the operation request through each input interface, and controls the operation test of the instrument according to the output control command pre-programmed according to the software system and method documentation, and manages the state of the instrument. And output the corresponding information to an external computer, printer, touch display through the output device; the automatic sample loading module operates on the pump and the mechanical arm of the liquid path system according to the instruction of the main control board; the photocell and other sensors provide the necessary information for the instrument;
  • the external interface board provides an interface to connect to an external computer and an external bar code scanner to input and output information.
  • the working principle of the fully automatic fluorescent immunoassay analyzer is as follows:
  • the automatic fluorescent immunoassay analyzer moves to the sample module 6 through the XYZ moving robot arm of the loading module 7, and picks up the disposable tip in the disposable tip box 17 through the disposable tip picker 12 of the Z arm 11 Moving to the top of the sample unit 20, the Z-arm 11 moves up and down, and the syringe pump 42 sucks the sample in the sample tube through the disposable tip.
  • the instrument selects whether to perform dilution according to different test items, and if not diluted, the XYZ motion
  • the mechanical arm directly sends the disposable tip to the reagent strip at the position of the reagent strip slot 26, and the loaded reagent strip completes the reaction on the reaction tray.
  • the reagent strip is rotated to the detection module 5, The detection is completed by the optical detecting device 39, and then the reagent The strip is pushed out of the instrument; if the sample needs to be diluted, the XYZ moving robot raises the sample sucked by the disposable tip into the diluent tank 19, and simultaneously fills the diluent tank 19 by drawing an appropriate amount of the diluent. The syringe pump 42 repeatedly sucks and draws the sample and the diluent is thoroughly mixed. After fully mixing, the XYZ moving robot arm sends the disposable tip to the reagent strip at the position of the reaction strip reagent strip slot 26, and the loaded reagent strip is The reaction is completed on the reaction disk. After the reaction is completed, the reagent strip is rotated to the detection module 5, and the detection is completed by the optical detection device 39, and then the reagent strip is pushed out of the instrument.
  • the disposable tip picker 12 is moved to the needle washing tank 41, and the washing liquid bottle 44 washes the disposable tip picker 12, and the waste liquid flows into the waste liquid bottle 43 through the pipe.
  • a fully automatic fluorescent immunoassay analyzer, the reagent strip storage and automatic loading module 3 and the associated reaction disk module 4 have the following specific structures, and other module configurations are similar to those of the first embodiment.
  • the reaction disk module 4 is a disk-shaped device, and a plurality of reagent strip slots 26 are fixed at the edge of the disk, wherein the slot mouth and the reagent strip outlet 27 correspond to each other, as shown in FIG. 7.
  • the reagent strip storage and automatic loading module 3 includes a reagent strip storage box 32, a storage box holder 33 and an automatic loading unit 45.
  • the storage box holder 33 is fixed on the support base plate 1, and the reagent strip is stored.
  • the case 32 is fixed to the bracket by a latch 34.
  • the automatic loading assembly 45 is composed of a second motor 35, a second synchronous wheel 36, a second timing belt 37, and a flexible hanger 38.
  • the control system controls the second motor 35 to operate, drives the second synchronous wheel 36, the second timing belt 37, and the elastic hanging rod 38 to move, hooks the reagent strip at the bottom of the reagent strip storage box 32, and sends the reagent strip to the reagent strip of the reaction tray.
  • the elastic hanger 38 is a rod located below the reaction tray reagent strip slot 26 and reciprocates along the line of the slot below the reaction tray and storage case.
  • the front end of the elastic hanging rod 38 has a resilient hook with a pressing force. When working, it enters under the reagent strip, and the hook is pressed down by the reagent strip until it enters the groove below the reagent strip to recover. The movement moves back from the storage box to the reagent strip slot of the reaction tray, and the hook is re-entered when exiting. Press down to exit the reagent strip groove.
  • the reagent strip storage box 32 includes a box body and a lid portion, and the box body and the lid are fixed by slots, screws, and the like. The method is sealed; the reagent strip storage box 32 has a reagent strip descending guide 46; the reagent strip storage box 32 has a notch 47 at the bottom; the reagent strip storage box 32 has a sealing elastic piece 48 near the bottom end of the notch 47; the reagent strip storage box 32 A desiccant hub 49 for the desiccant is placed on the surrounding wall.
  • the notch 47 extends from the bottom end side of the reagent strip storage case 32 to the other side, and may extend from a notch corresponding to the reagent strip to the other side of the bottom end.
  • the sealing shrapnel 48 can only be bounced externally to the reagent strip storage case 32.
  • the reagent strip descending rail 46 may be a rail that abuts the inner wall of the reagent strip storage box 32, or may be a rail that is suspended from the top, and the reagent strip descending rail 46 is away from the reagent strip storage box.
  • the distance between the bottom ends of 32 is between 1-2 strip thicknesses.
  • the automatic fluorescent immunoassay analyzer of the present embodiment there are three reagent strip storage and automatic loading modules 3, and three reagent strips are loaded each time.
  • the sample loading module 7 adds the sample to the reagent strip in the Nth reaction disk slot, and the detection module 5 detects the reagent strip in the N+13 position reagent strip slot. After the test is completed, the reaction plate position without the reagent strip is rotated to the automatic loading area, and the reagent strip is automatically loaded into the reaction tray through the elastic hook to start a new cycle.
  • the reagent strip loading process is as follows:
  • the reagent strip is placed in the reagent strip storage box 32.
  • the desiccant is placed in the desiccant insertion hole 49 of the reagent strip storage box 32, and the plug is inserted.
  • the tank, the screw, and the like are fixed to seal the reagent strip storage case 32.
  • the reagent strip storage box 32 storing the reagent strip is placed in the slot of the bracket assembly, and the reagent cartridge fixing buckle 34 is fastened to fix the reagent strip storage box 32.
  • the second synchronizing wheel 36 on the second motor 35 drives the second timing belt 37, thereby driving the elastic hanger 38, the elastic hook 38 at the bottom notch 47 of the reagent strip storage case 32 and
  • the reagent strip track 51 shown in Fig. 11 moves linearly, and the reagent strip is pulled out from the reagent strip storage case 32 by the sealing elastic piece 48, and the number of remaining reagent strips is counted by the sensor 50.
  • the reagent strip in the reagent strip storage box 32 can only move along the guide rail due to the action of the reagent strip lowering guide rail 46, and falls from the top of the reagent strip storage box 32 to the bottom under the action of gravity, thereby realizing automatic loading of the reagent strip.
  • a fully automatic fluorescent immunological quantitative analysis device the detection module 5 is provided with an elastic hook, and other module configurations are similar to those of the second embodiment.
  • the elastic hook under the detection module 5 pushes the reagent strip out of the reaction tray and enters below the detection device.
  • the previous reagent strip is pushed out of the device of the present embodiment by the next reagent strip, and the next reagent strip remains below the detection device.
  • the present invention discloses a fully automatic fluorescent immunological quantitative analysis method, which comprises the following steps:
  • Step 1) reagent strip storage and automatic loading module loading reagent strip into the reagent strip slot in the reaction tray;
  • Step 2 The reaction tray starts to rotate, and the reagent strip in the first position enters the sample loading area with the rotation, and the sample loading module sucks the sample in the module to add the reagent strip addition port to start the immunochromatographic reaction;
  • Step 3 the reaction tray continues to rotate, the reagent strip in the first position leaves the sample application area, and the reagent strips in the subsequent position enter the sample application area one after another, and are successively paused to complete the sample loading;
  • Step 4) The reaction tray continues to rotate, and the detection module of the first position of the reagent strip rotates, and the detection device completes the detection of the reagent strip at the first position, and sends the result to the computer for processing.
  • the reagent strip loading method is to hook the reagent strip from the reagent strip storage box by the elastic hook of the elastic hook of the loading device.
  • the loading step includes the following two cases:
  • sample loading device first picks up the disposable tip, then moves to the sample area to take the sample, then moves to the reaction plate area to complete the sample loading process, and then the sample loading device moves to the disposable tip collection box recovery port. Remove the disposable tip and perform a new round of loading;
  • the sample loading device first picks up the disposable tip, and the sample area of the movement absorbs the sample, then moves to the dilution tank to add the sample to the dilution tank, and then sucks the diluent into the sample, and repeatedly draws and samples the sample. After dilution, move to the reaction plate loading area to complete the sample loading, then carry out the disposable tip recovery, and then pick up the new tip for a new round of loading after moving to the disposable tip box.
  • a plurality of samples can be discharged in the sample module, which is not limited in the present invention.
  • the elastic hanging under the detecting device The hook pushes the reagent strip out of the reaction tray and enters below the detection device.
  • the previous reagent strip is pushed out of the device by the next reagent strip, and the next reagent strip is left under the detection device.
  • the reaction disk position without the reagent strip is rotated to the automatic loading area, and the reagent strip is automatically loaded into the reaction disk through the elastic hook to start a new cycle.

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Abstract

一种全自动荧光免疫定量分析装置及检测方法，属于定量荧光免疫分析检测领域。该免疫定量分析装置包括支撑底板（1）、试剂条存储及自动加载模块（3）、反应盘模块（4）、检测模块（5）、样本模块（6）、加样模块（7）、洗涤模块（8）和控制系统，试剂条存储及自动加载模块（3）、反应盘模块（4）、检测模块（5）、样本模块（6）、加样模块（7）、洗涤模块（8）依次排列在支撑底板（1）上，所述试剂条存储及自动加载模块（3）为反应盘模块（4）提供试剂条，加样模块（7）将样本模块（6）中的样本，加入到反应盘模块（4）中进行反应，完成反应后进入检测模块（5）完成检测。解决了体外诊断产品难以实现自动化的难题，减少了人为误差，提高了测试的精准度，提高了检测效率。

Description

一种全自动荧光免疫定量分析装置及检测方法 技术领域
本发明属于定量荧光免疫分析检测领域，特别是涉及一种全自动荧光免疫定量分析方法及装置。
背景技术
POCT，即时检验(point-of-care testing)是体外诊断器械(IVD)的一个细分行业，即现场采样即刻分析，省去标本在实验室检验的复杂程序，快速得到检验结果。
在进行荧光免疫定量检测时，目前市场上的大多数诊断仪器都是半自动检测仪器，比如南京基蛋生物科技有限公司现有的荧光免疫层析分析仪GP1100就是半自动的检测仪器，其机器结构只包括一个用于定量检验的光路系统和电子显示系统，加样、层析过程都是手工在机器外面完成的；在使用上，首先由于半自动仪器在室外进行加样，对于一些对温度要求很高的产品检验十分不利；其次，因为需要进行人工采样及加样步骤，再经过仪器进行定量分析，增大了人工干预的所产生的测试误差，免疫层析展层时间，加样精度等都不准确，测试速度慢，人工加样容易造成生物污染；最后现有的小型检测仪器大多数是一次只能加载一个样本，完成检测结束后再向其中加入另一块样本。这就造成了以下缺点：必须有专门的人工值守，反复操作加载样本，人工干预造成生物污染，同时检测人员无法离开去进行其他检测工作；另外，一次一个进行检测，效率低下，延误病情诊断；室外加样不适用于温度要求高的产品检测。
发明内容
为了克服现有技术的不足，本发明公开了一种全自动荧光免疫定量分析装置及其检测方法，该装置能够重复连续的进行荧光免疫定量检测工作，灵敏度高、操作简便、重复性高。
本发明所采用的技术方案如下：一种全自动荧光免疫定量分析装置，包括支撑底板、试剂条存储及自动加载模块、反应盘模块、检测模块、样本模块、加样模块、洗涤模块和控制系统，所述试剂条存储及自动加载模块、反应盘模块、检测模块、样本模块、加样模块、洗涤模块依次排列在支撑底板上，所述试剂条存 储及自动加载模块为反应盘模块提供试剂条，加样模块将样本模块中的样本，加入到反应盘模块中进行反应，完成反应后进入检测模块完成检测。
所述加样模块包括一个XYZ运动机械臂、一次性吸头拾取器和注射泵；XYZ运动机械臂包括X臂、Y臂和Z臂，X臂沿样本模块和反应盘模块水平布置；Y臂位于样本模块上部，与X臂垂直相连，可在X臂上滑动；Z臂垂直固定在Y臂的滑动槽中，可沿Y臂做前后、上下滑动，Z臂底部安装一次性吸头拾取器。XYZ臂上均连接步进电机组件，控制系统控制步进电机组件，从而控制Y、Z臂滑动，从而使一次性吸头拾取器能够在样本模块和反应盘模块区域上下左右移动。
所述样本模块包括一次性吸头盒、混匀盒、稀释液槽、样品单元、吸头回收盒和样本模块盒，所述样品单元和稀释液槽位于样本模块盒底板上，底板上设有轨道，样品单元和稀释液槽底部设置与轨道配套的卡槽，样品单元和稀释液槽在底板轨道上前后滑动；样本模块盒一侧设置平台，平台下部隔空，吸头回收盒、一次性吸头盒和混匀盒排放在平台上，所述吸头回收盒部分穿过平台，在平台上，部分在平台下部隔空空间，吸头回收盒顶端设置回收口，底端不封口，吸头进入回收口后直接落入底板上，一次性吸头盒和混匀盒由支架框架支撑。
所述样本模块盒设置成抽屉状，左右两侧有挡板，挡板外侧有滑轮，可沿外侧的滑轨上前后滑动，挡板前端有一固定插销，用于固定抽屉。
所述反应盘模块为一圆盘状的装置，圆盘边缘固定试剂条插槽，插槽口和试剂条存储及自动加载模块的试剂条出口位置对应，加载试剂条；反应盘将试剂条带到加样模块所对应的位置完成加样操作；反应盘将试剂条带到检测模块所对应的位置完成检测操作。
所述反应盘与第一电机连接，第一电机通过驱动第一同步轮、第一同步带，带动反应盘转动；反应盘试剂条插槽为2N或2N+1个，N≥1，试剂条插槽优选16-20个，更为优选试剂条插槽为16个。
所述试剂条存储及自动加载模块包括试剂条存储盒、存储盒支架和自动加载组件，存储盒支架固定在支撑底板上，试剂条存储盒通过扣锁固定在存储盒支架上；自动加载组件由第二电机、第二同步轮、第二同步带和弹性挂杆组成，控制系统控制第二电机运转，带动第二同步轮、第二同步带、弹性挂杆运动。所述的 反应盘模块中设置试剂条插槽，下底面中间有缺口，所述缺口可让弹性挂杆送试剂条入试剂条插槽内。所述弹性挂杆为一杆状物，位于反应盘试剂条插槽下方，可沿插槽这一直线在反应盘和存储盒下方往复运动，其前端杆部有一带可下压的弹性挂钩。当工作时，其进入试剂条下方，挂钩被试剂条下压直至进入试剂条下方凹槽恢复，往回运动从存储盒中带出试剂条直至反应盘试剂条插槽中，退出时挂钩再被下压退出试剂条凹槽。
所述试剂条存储盒包括盒体和盒盖部分，盒体、盒盖密封；试剂条存储盒内有试剂条下降导轨；所述试剂条存储盒的底部有一缺口，试剂条存储盒侧面靠近该缺口的底端有一密封弹片；所述的缺口从试剂条存储盒的底端一侧向另一侧延伸，其延伸长度可以从刚刚可以对应试剂条的槽口至底端另一侧，所述的密封弹片只可以向试剂条存储盒外部弹。
所述试剂条存储及自动加载装置模块有1-3个。
所述试剂条存储盒的四周壁上有用于放置干燥剂的干燥剂插孔。
所述试剂条下降导轨可以是紧贴试剂条存储盒盒体内壁的导轨，或者是从顶部悬挂而下的导轨，试剂条下降导轨距离试剂条存储盒的底端的距离为1-2个试剂条厚度之间。
可在试剂条存储盒支架组件上设置传感器，通过传感器对剩余试剂条数目进行统计。
所述检测模块设置于支撑底板上，并且位于反应转盘的周边，使得反应盘中试剂条转动后能在其下检测。检测模块包含光学检测装置，反应盘中试剂条转动至检测装置下，完成荧光检测。
所述检测模块底部设置弹性挂杆，检测模块完成试剂条检测后，检测模块下的弹性挂杆将试剂条从反应盘中推出，进入到检测装置下方。待下一个试剂条完成检测后，上一个试剂条被下一个试剂条推出本实施例装置，下一个试剂条留在检测装置下方。测模块底部的弹性挂杆与上述反应盘试剂条插槽下方的弹性挂杆机构原理一样。
所述洗涤模块包括洗针槽、废液瓶、洗液瓶，洗针槽内有导管与废液瓶、洗液瓶相连。加样完成后一次性吸头拾取器移动到洗针槽，洗液瓶中洗液清洗一次性吸头拾取器，废液通过管路流入废液瓶。
本发明另一个目的，提供一种全自动荧光免疫定量分析的检测方法，包括以下步骤：
步骤1：试剂条存储及自动加载模块加载试剂条进入反应盘中的试剂条插槽中；
步骤2：所述反应盘启动转动，第一位置的试剂条随着转动进入加样区域，停顿，加样模块吸取样本模块中的样品加入试剂条加样口，开始进行免疫层析反应；
步骤3：所述反应盘继续转动，第一位置试剂条离开加样区域，后续位置试剂条先后进入加样区域，逐次停顿，完成加样；
步骤4：所述反应盘继续转动，第一位置试剂条转动至检测模块，停顿，检测装置完成对第一位置试剂条检测，并将结果发送至计算机进行处理。
所述加样步骤包括以下两种情况：
A样品不需要稀释：加样装置首先拾取一次性吸头，后运动至样本区域吸取样本，然后再运动至反应盘区域完成加样过程，然后加样装置运动至一次性吸头回收盒回收口处除下一次性吸头，然后进行新一轮加样；
B样品需要稀释：加样装置首先拾取一次性吸头，运动之样本区域吸取样本，后运动至稀释液槽将样本加入稀释液槽中，再吸取稀释液加注进去后，反复吸取打出将样本稀释后，运动至反应盘加样区域完成加样，再进行一次性吸头回收，后在运动至一次性吸头盒处拾取新吸头进行新一轮加样。
所述样本模块中可以排放多种样本。
本发明有益效果：
本发明通过提供一种全自动荧光免疫定量分析装置，解决了体外诊断产品难以实现自动化的难题，通过一次性吸样装置避免了交叉污染，反应时间控制精确，提高了仪器的重复性跟测试准确度，实现了快速诊断仪器的自动化测试，减少了人为误差，提高了测试的精准度，提高了检测效率。
本发明可以实现多种样本一起检测。本发明同时适用直接加样检测和需要稀释样品检测。
本发明在试剂条存储盒中加入干燥孔，能够保证试剂条的干燥，提高检测的准确度。
本发明含有液路洗针系统，能够保证一次性吸头拾取器清洁，从而使吸取的样品不受污染。
附图说明
图1全自动荧光免疫定量分析装置控制系统架构示意图。
图2全自动荧光免疫定量分析装置立体图。
图3全自动荧光免疫定量分析装置俯视图。
图4全自动荧光免疫定量分析装置支架结构示意图。
图5样本模块结构示意图。
图6反应盘模块结构示意图。
图7反应盘未加试剂条存储结构示意
图8试剂条存储即自动加载模块结构示意图。
图9试剂条存储盒和支架组件结构示意图。
图10试剂条存储盒的外部结构示意图。
图11试剂条存储盒的内部结构示意图。
图12试剂条存储盒自动弹出装置的结构示意图。
图13全自动荧光免疫定量分析方法流程示意图。
图中：1为支撑底板、2为电路箱、3为试剂条存储及自动加载模块、4为反应盘模块、5为检测模块、6为样本模块、7为加样模块、8为洗涤模块、9为X臂、10为Y臂、11为Z臂、12为一次性吸头拾取器、13为步进电机组件、14为滑轮、15为滑轨、16为固定插销、17为一次性吸头盒、18为混匀盒、19为稀释液槽、20为样品单元、21为吸头回收盒、22为轨道、23为平台、24为回收口、25为支架、26为试剂条插槽、27为试剂条出口、28为试剂条插槽缺口、29为第一电机、30为第一同步轮、31为第一同步带，32为试剂条存储盒、33为存储盒支架、34为扣锁、35为第二电机、36为第二同步轮、37为第二同步带、38为弹性挂杆、39光学检测装置、40为前箱板、41为洗针槽、42为注射泵、43为洗液瓶、44为废液瓶、45为自动加载组件、46为试剂条下降导轨、47为缺口、48为密封弹片、49为干燥剂插孔、50为传感器、51为试剂条轨道。
具体实施方式
下面结合附图对本发明全自动荧光免疫定量分析装置及其检测方法作详细 的说明。
实施例1
如图2、3、4所示，一种全自动荧光免疫定量分析装置，包括支撑底板1和控制系统，还包括在底板上依次排列的试剂条存储及自动加载模块3、反应盘模块4、检测模块5、样本模块6、加样模块7和洗涤模块8；试剂条存储及自动加载装置3为反应盘模块4提供试剂条，加样模块7将样本模块6中的样本加到反应盘模块4的试剂条上进行反应，完成反应后进入检测模块5完成检测。
如图2、4所示，所述的加样模块7包括一个XYZ运动机械臂和一次性吸头拾取器12；X臂9水平布置，可位于电路箱2顶端，Y臂10位于样本模块6上部，与X臂9垂直相连，Y臂10可在X臂9上滑动，Z臂11垂直固定在Y臂10的滑动槽中，可沿Y臂10做前后、上下滑动。Z臂11底部安装一次性吸头拾取器12。XYZ臂上均连接步进电机组件13，步进电机组件13由系统控制，可以控制Y、Z臂滑动，从而使一次性吸头拾取器12能够在样本模块6和反应盘模块4区域上下左右移动。电路箱2里包括线路、主控板等各种控制装置。
如图5所示，所述的样本模块6为一抽屉状装置，左右两侧有挡板，挡板外侧有滑轮14，可沿外侧的滑轨15上前后滑动，挡板前端有一固定插销16，可将抽屉固定；模块内包括一次性吸头盒单元17、混匀盒18、稀释液槽19、样品单元20和吸头回收盒21；所述样品单元20位于抽屉底板上，通过底板上的轨道22固定并可以前后滑动抽出；抽屉上设有平台23，将其下部隔空，吸头回收盒21、一次性吸头盒17和混匀盒18依次排放在平台23上，所述吸头回收盒21一部分穿过平台23在平台23上，一部分在平台23下，吸头回收盒21顶端设有回收口24，底端为空，吸头进入回收口24后直接落入底板上，一次性吸头盒17和混匀盒18由支架25框架支撑。稀释液槽19位于样品单元20和平台23之间，也是有底板轨道22固定在底板上。
如图6所示，所述的反应盘模块4为一圆盘状的装置，圆盘边缘固定着16-20个试剂条插槽26，其中的插槽口和试剂条存储及自动加载模块3的试剂条出口27位置对应，试剂条存储及自动加载模块3可以推送试剂条入试剂条插槽26内；反应盘模块4下部穿过底板和底板底部第一电机29相连，第一电机29与控制系统相连，控制系统通过调控第一电机29，带动第一同步轮30、第一同步带31， 最终控制反应盘的转动。
如图3、6所示，所述检测模块5位于试剂条存储及自动加载装置3和电路箱2之间，其上有一免疫荧光检测装置39，反应盘中试剂条转动至检测装置下，完成荧光检测。
如图2、3、4所示，所述的电路箱2为固定在底板1上，包括箱顶、前箱板40、后箱板和侧箱板；其中前箱板上有一洗针槽41，槽内有导管与位于侧箱板外的废液瓶44、洗液瓶43相连；前箱板上还有一注射泵42，其与一次性吸头拾取器12相连。
本发明装置还相应信息通过输出模块，例如外部计算机、打印机、触摸显示屏
如图1所示，所述全自动荧光免疫分析装置控制系统，包括电源接口(P1)、主控制板、触摸显示屏、外置接口(P10)、RFID模块、扫码器模块、打印机模块、光电池信号输入、电机驱动器组、电机、自动加样模块、红外传感器及其他传感器；电源接口由市电经电源滤波器，滤除噪声，然后由开关电源转换为24V直流电源，提供给主控制板及相关模块。主控制板为仪器控制中心，装载主控制程序，采集各路传感器信息，经各输入接口接受操作请求，依软件系统及方法文档预先编制的输出控制指令，操纵仪器运行检测试验，管理仪器状态，并将相应信息通过输出装置输出至外部计算机、打印机、触摸显示屏；自动加样模块根据主控制板的指令对液路系统各泵、机械臂运作；光电池及其他传感器为仪器提供必要的信息；外置接口板提供接口与外联计算机、外接条码扫描器连接，输入及输出信息。
在本实施例中，全自动荧光免疫定量分析装置工作原理如下：
全自动荧光免疫定量分析装置通过加样模块7的XYZ运动机械臂移动到样本模块6，通过Z臂11的一次性吸头拾取器12在一次性吸头盒17拾取一次性吸头，机械臂移动到样品单元20上方，通过Z臂11上下运动，注射泵42通过一次性吸头吸取样品管中样品，吸取完毕后，仪器根据不同的测试项目来选择是否进行稀释，如果没有稀释，XYZ运动机械臂直接将一次性吸头送至反应盘试剂条插槽26位置上的试剂条上，加样完毕的试剂条在反应盘上完成反应，待反应完成后，试剂条转动至检测模块5，由光学检测装置39完成检测，随后试剂 条被推出仪器外；如果样本需要稀释，XYZ运动机械臂将一次性吸头吸取到的样品加注到稀释液槽19中，同时在吸取适量的稀释液加注到稀释液槽19中，通过注射泵42反复吸取打出将样品与稀释液充分混合，充分混合后，XYZ运动机械臂将一次性吸头送至反应盘试剂条插槽26位置上的试剂条上，加样完毕的试剂条在反应盘上完成反应，待反应完成后，试剂条转动至检测模块5，由光学检测装置39完成检测，随后试剂条被推出仪器外。
加样完成后一次性吸头拾取器12移动到洗针槽41，洗液瓶44中洗液清洗一次性吸头拾取器12，废液通过管路流入废液瓶43。
实施例2
一种全自动荧光免疫定量分析装置，试剂条存储及自动加载模块3和配套的反应盘模块4具体结构如下，其他模块构造与实施例1类似。
如图6所示，所述的反应盘模块4为一圆盘状的装置，圆盘边缘固定着多个试剂条插槽26，其中的插槽口和试剂条出口27位置对应，如图7所示，试剂条插槽26下底面中间有缺口28，所述缺口28可让弹性挂杆38送试剂条入试剂条插槽26内；反应盘模块4下部穿过底板和底板底部第一电机29相连，第一电机29与控制系统相连，控制系统通过调控第一电机29，带动第一同步轮30、第一同步带31，最终控制反应盘的转动。
如图8、9所示，所述的试剂条存储及自动加载模块3包括试剂条存储盒32、存储盒支架33和自动加载组件45，存储盒支架33固定在支撑底板1上，试剂条存储盒32通过扣锁34固定在支架上。自动加载组件45由第二电机35、第二同步轮36、第二同步带37和弹性挂杆38组成。控制系统控制第二电机35运转，带动第二同步轮36、第二同步带37、弹性挂杆38运动，钩出试剂条存储盒32底部的试剂条，将试剂条送入反应盘的试剂条插槽26中。如图12所示，弹性挂杆38为一杆状物，位于反应盘试剂条插槽26下方，可沿插槽这一直线在反应盘和存储盒下方往复运动。弹性挂杆38前端杆部有一带可下压的弹性挂钩。当工作时，其进入试剂条下方，挂钩被试剂条下压直至进入试剂条下方凹槽恢复，往回运动从存储盒中带出试剂条直至反应盘试剂条插槽中，退出时挂钩再被下压退出试剂条凹槽。
试剂条存储盒32包括盒体和盒盖部分，盒体、盒盖通过插槽、螺钉固定等 方式密封；试剂条存储盒32内有试剂条下降导轨46；试剂条存储盒32的底部有一缺口47；试剂条存储盒32侧面靠近该缺口47的底端有一密封弹片48；试剂条存储盒32的四周壁上有用于放置干燥剂的干燥剂插孔49。
如图10所示，所述的缺口47从试剂条存储盒32的底端一侧向另一侧延伸，其延伸长度可以从刚刚可以对应试剂条的槽口至底端另一侧，所述的密封弹片48只可以向试剂条存储盒32外部弹。
如图11所示，所述的试剂条下降导轨46可以是紧贴试剂条存储盒32盒体内壁的导轨，也可以是从顶部悬挂而下的导轨，试剂条下降导轨46距离试剂条存储盒32的底端的距离为1-2个试剂条厚度之间。
如图8所示，在支架组件33上有传感器50，通过传感器50对剩余试剂条数目进行统计。
本实施例全自动荧光免疫定量分析装置中试剂条存储及自动加载模块3有3个，每次加载3个试剂条。反应盘试剂条插槽26有16个。所述加样模块7加入样品至第N个反应盘插槽中试剂条上，则所述检测模块5对第N+13位置试剂条插槽中的试剂条进行检测。检测完成后没有试剂条的反应盘位置转动至自动加载区域，通过弹性挂钩自动加载试剂条进入反应盘，开始新的循环。
在本实施例中，试剂条加载过程如下：
将试剂条放入试剂条存储盒32中，为了防止试剂条存储盒32内的试剂条潮湿而导致测量结果不准，试剂条存储盒32的干燥剂插孔49中放入干燥剂，通过插槽、螺钉等固定密封试剂条存储盒32。
将储存好试剂条的试剂条存储盒32放入支架组件的插槽内，扣紧试剂盒固定扣锁34，使试剂条存储盒32固定，
通过自动弹出装置的第二电机35转动，第二电机35上的第二同步轮36带动第二同步带37，从而带动弹性挂杆38，弹性挂钩38在试剂条存储盒32的底部缺口47和图11所示的试剂条轨道51上直线运动，通过密封弹片48将试剂条从试剂条存储盒32中拨出，并通过传感器50对剩余试剂条数目进行统计。
试剂条存储盒32中的试剂条由于试剂条下降导轨46的作用，只能沿着导轨运动，在重力作用下，从试剂条存储盒32上面落至底部，从而实现了试剂条的自动加载。
实施例3
一种全自动荧光免疫定量分析装置，检测模块5设置弹性挂钩，其他模块构造与实施例2相似。
检测模块5完成试剂条检测后，检测模块5下的弹性挂钩将试剂条从反应盘中推出，进入到检测装置下方。待下一个试剂条完成检测后，上一个试剂条被下一个试剂条推出本实施例装置，下一个试剂条留在检测装置下方。
实施例4
如图13所示，本发明公开了一种全自动荧光免疫定量分析方法，该方法包括以下步骤：
步骤1)试剂条存储及自动加载模块加载试剂条进入反应盘中的试剂条插槽中；
步骤2)反应盘启动转动，第一位置的试剂条随着转动进入加样区域，停顿，加样模块吸取样本模块中的样品加入试剂条加样口，开始进行免疫层析反应；
步骤3)反应盘继续转动，第一位置试剂条离开加样区域，后续位置试剂条先后进入加样区域，逐次停顿，完成加样；
步骤4)反应盘继续转动，第一位置试剂条转动之检测模块，停顿，检测装置完成对第一位置试剂条检测，并将结果发送至计算机进行处理。
上述方法中试剂条加载方法是通过加载装置下一带弹性挂钩的弹性挂杆从试剂条存储盒中钩出试剂条。
本发明分析方法中，所述加样步骤包括以下两种情况：
A样品不需要稀释：加样装置首先拾取一次性吸头，后运动至样本区域吸取样本，然后再运动至反应盘区域完成加样过程，然后加样装置运动至一次性吸头回收盒回收口处除下一次性吸头，然后进行新一轮加样；
B样品需要稀释：加样装置首先拾取一次性吸头，运动之样本区域吸取样本，后运动至稀释液槽将样本加入稀释液槽中，再吸取稀释液加注进去后，反复吸取打出将样本稀释后，运动至反应盘加样区域完成加样，再进行一次性吸头回收，后在运动至一次性吸头盒处拾取新吸头进行新一轮加样。
本发明分析方法中，所述样本模块中可以排放多种样本，本发明不做限定。
本发明分析方法中，所述的检测装置检测完试剂条后，检测装置下的弹性挂 钩将试剂条从反应盘中推出，进入到检测装置下方，待下一个试剂条完成检测后，上一个试剂条被下一个试剂条推出本发明装置，下一个试剂条留在检测装置下方。所述检测完成后没有试剂条的反应盘位置转动至自动加载区域，通过弹性挂钩自动加载试剂条进入反应盘，开始新的循环。

Claims (11)

  1. 一种全自动荧光免疫定量分析装置，其特征在于，包括支撑底板(1)、试剂条存储及自动加载模块(3)、反应盘模块(4)、检测模块(5)、样本模块(6)、加样模块(7)、洗涤模块(8)和控制系统，所述试剂条存储及自动加载模块(3)、反应盘模块(4)、检测模块(5)、样本模块(6)、加样模块(7)、洗涤模块(8)依次排列在支撑底板(1)上，所述试剂条存储及自动加载模块(3)为反应盘模块(4)提供试剂条，加样模块(7)将样本模块(6)中的样本，加入到反应盘模块(4)中进行反应，完成反应后进入检测模块(5)完成检测。
  2. 根据权利要求1所述的免疫定量分析装置，其特征在于，所述加样模块(7)包括一个XYZ运动机械臂、一次性吸头拾取器(12)和注射泵(42)；XYZ运动机械臂包括X臂(9)、Y臂(10)和Z臂(11)，X臂(9)沿样本模块(6)和反应盘模块(4)水平布置；Y臂(10)位于样本模块(6)上部，与X臂(9)垂直相连，在X臂上滑动；Z臂(11)垂直固定在Y臂(10)的滑动槽中，Z臂(11)底部安装一次性吸头拾取器(12)，注射泵(42)与一次性吸头拾取器(12)连接，为一次性吸头拾取器(12)提供取样动力。
  3. 根据权利要求1所述的定量分析装置，其特征在于，所述样本模块(6)包括一次性吸头盒(17)、混匀盒(18)、稀释液槽(19)、样品单元(20)、吸头回收盒(21)和样本模块盒，所述样品单元(20)和稀释液槽(19)位于样本模块盒底板上，底板上设有轨道(22)，样品单元(20)和稀释液槽(19)底部设置与轨道(22)配套的卡槽，样品单元(20)和稀释液槽(19)在底板轨道(22)上前后滑动；样本模块盒一侧设置平台(23)，平台(23)下部隔空，吸头回收盒(21)、一次性吸头盒(17)和混匀盒(18)排放在平台(23)上，所述吸头回收盒(21)部分穿过平台(23)在平台(23)上，部分在平台(23)下部隔空空间，吸头回收盒顶端设置回收口(24)，底端不封口，吸头进入回收口后直接落入底板上。
  4. 根据权利要求3所述的定量分析装置，其特征在于，所述样本模块盒设置成抽屉状，左右两侧有挡板，挡板外侧有滑轮(14)，可沿外侧的滑轨(15)上前后滑动，挡板前端有一固定插销(16)，用于固定抽屉。
  5. 根据权利要求1所述的定量分析装置，其特征在于，所述反应盘模块(4)为一圆盘状的装置，圆盘边缘固定试剂条插槽(26)，插槽口和试剂条存储及自动 加载模块(3)的试剂条出口(27)位置对应，加载试剂条；反应盘将试剂条带到加样模块(7)所对应的位置完成加样操作；反应盘将试剂条带到检测模块(5)所对应的位置完成检测操作。
  6. 根据权利要求5所述的定量分析装置，其特征在于，所述反应盘与第一电机(29)连接，第一电机(29)驱动第一同步轮(30)、第一同步带(31)，带动反应盘转动；所述反应盘试剂条插槽(26)为2N或2N+1个，N≥1。
  7. 根据权利要求1所述的定量分析装置，其特征在于，所述试剂条存储及自动加载模块(3)包括试剂条存储盒(32)、存储盒支架(33)和自动加载组件(45)，存储盒支架(33)固定在支撑底板(1)上，试剂条存储盒(32)通过扣锁(34)固定在存储盒支架(33)上；自动加载组件(45)由第二电机(35)、第二同步轮(36)、第二同步带(37)和弹性挂杆(38)组成，控制系统控制第二电机(35)运转，带动第二同步轮(36)、第二同步带(37)、弹性挂杆(38)运动；所述的反应盘模块(4)中设置试剂条插槽(26)，下底面中间有缺口(28)，所述缺口(28)可让弹性挂杆(38)送试剂条入试剂条插槽(26)内。
  8. 根据权利要求7所述的定量分析装置，其特征在于，所述试剂条存储盒(32)包括盒体和盒盖部分，盒体、盒盖密封；试剂条存储盒(32)内有试剂条下降导轨(46)；所述试剂条存储盒(32)的底部有一缺口(47)，试剂条存储盒(32)侧面靠近该缺口(47)的底端有一密封弹片(48)；所述的试剂条存储及自动加载装置模块(3)有1-3个。
  9. 根据权利要求1所述的定量分析装置，其特征在于，所述洗涤模块(8)包括洗针槽(41)、废液瓶(44)、洗液瓶(43)，洗针槽(41)内有导管与废液瓶(44)、洗液瓶(43)相连。
  10. 权利要求1所述全自动荧光免疫定量分析装置的检测方法，其特征在于，包括以下步骤：
    步骤1：试剂条存储及自动加载模块加载试剂条进入反应盘中的试剂条插槽中；
    步骤2：所述反应盘启动转动，第一位置的试剂条随着转动进入加样区域，停顿，加样模块吸取样本模块中的样品加入试剂条加样口，开始进行免疫层析反应；
    步骤3：所述反应盘继续转动，第一位置试剂条离开加样区域，后续位置试剂条先后进入加样区域，逐次停顿，完成加样；
    步骤4：所述反应盘继续转动，第一位置试剂条转动之检测模块，停顿，检测装置完成对第一位置试剂条检测，并将结果发送至计算机进行处理。
  11. 根据权利要求10所述的检测方法，其特征在于，所述加样步骤为以下两种情况中任一：
    A样品不需要稀释：加样装置首先拾取一次性吸头，后运动至样本区域吸取样本，然后再运动至反应盘区域完成加样过程，然后加样装置运动至一次性吸头回收盒回收口处除下一次性吸头，然后进行新一轮加样；
    B样品需要稀释：加样装置首先拾取一次性吸头，运动之样本区域吸取样本，后运动至稀释液槽将样本加入稀释液槽中，再吸取稀释液加注进去后，反复吸取打出将样本稀释后，运动至反应盘加样区域完成加样，再进行一次性吸头回收，后在运动至一次性吸头盒处拾取新吸头进行新一轮加样。
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